Liquidia Technologies has announced interim data from the Phase 3 INSPIRE trial of its LIQ861 DPI treprostinil for the treatment of pulmonary arterial hypertension demonstrating that LIQ861 was well-tolerated at doses of up to about 125 μg in PAH patients after two weeks, a safety endpoint requested by the FDA. The company announced initiation of the study in January 2018, and PK results are expected in the second quarter of 2019.
According to Liquidia, doses of up to about 150 μg of LIQ861 have been evaluated since the completion of the two-week assessment, and a maximum tolerated dose has yet to be determined. The trial is continuing to enroll patients for a sub-study to compare bioavailability and PK as PAH patients transition from nebulized treprostinil to the LIQ861 DPI.
Liquidia Senior VP of Product Development and LIQ861 Program Lead Robert Roscigno commented, “Patient demographics and baseline characteristics in the trial suggest that LIQ861 may be attractive across disease severity and may have utility as a first-line prostacyclin. Interestingly, enrollment of the safety portion of the trial was driven primarily by stronger than anticipated interest from New York Heart Association Functional Class II add-on patients, which may imply that dry-powder delivery could be an alternative to oral delivery in prostacyclin naïve patients. We are pleased with these findings and believe they support the therapeutic potential and versatility of LIQ861 among patients across different functional classes.”
The company said that it expects to submit the complete NDA for LIQ861 in late 2019.
Read the Liquidia press release.
